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Adefovir dipivoxil in the treatment of chronic hepatitis B
1Clinical Pharmacy Practice, Arnold and Marie Schwartz College of Pharmacy, Long Island University, Brooklyn, NY, USA. arivkina@liu.edu
Insights
Adefovir dipivoxil is a new treatment for chronic hepatitis B (CHB) that improves liver health and viral markers. It is effective for both HBeAg-positive and HBeAg-negative CHB, and for patients resistant to lamivudine.
Area of Science:
- Hepatology
- Virology
- Pharmacology
Background:
- Chronic hepatitis B (CHB) affects 400 million people globally.
- Current treatments like interferon alfa-2b and lamivudine have limitations.
- Adefovir dipivoxil represents a novel acyclic nucleotide analog for CHB treatment.
Purpose of the Study:
- To evaluate the efficacy and properties of adefovir dipivoxil in treating CHB.
- To compare adefovir dipivoxil with existing treatment options.
Main Methods:
- Comprehensive literature searches of MEDLINE and PubMed from 1966 to December 2003.
- Inclusion of randomized controlled studies, meta-analyses, and original meeting abstracts.
- Manual searches of references from retrieved primary and secondary literature.
Main Results:
- Adefovir dipivoxil (10 mg/day for 48 weeks) improved liver histology in 28% of HBeAg-positive and 31% of HBeAg-negative CHB patients versus placebo.
- Significant improvements in virologic and biochemical parameters were observed in both patient groups.
- Adefovir dipivoxil demonstrated efficacy against lamivudine-resistant CHB and had minimal adverse effects at the approved dose.
Conclusions:
- Adefovir dipivoxil offers a significant new therapeutic option for CHB.
- It is suitable as an initial treatment and for patients with lamivudine-resistant CHB.
- The drug addresses limitations of current CHB therapies.
Objective:
To evaluate properties of the new acyclic nucleotide analog adefovir dipivoxil in the treatment of chronic hepatitis B (CHB).
Data Sources:
MEDLINE and PubMed searches from 1966 to December 2003 were performed with the headings chronic hepatitis B, interferon alfa-2b, lamivudine, liver transplant, and adefovir dipivoxil.
Study Selection And Data Extraction:
Randomized controlled studies and meta-analyses were evaluated in detail. A manual search was performed using references from retrieved primary literature, review articles, editorials, postgraduate course syllabi from national meetings, and textbooks. Emphasis was placed on controlled, prospective, randomized trials. National meeting abstract presentations were included if the information offered was original.
Data Synthesis:
CHB is a major viral infection with an estimated 400 million carriers worldwide. Medications available to treat CHB include interferon alfa-2b and lamivudine, both agents having significant limitations. Adefovir dipivoxil is a novel nucleotide analog which, when given at 10 mg/day for 48 weeks, improved liver histology in 28% more patients with hepatitis B e antigen (HBeAg)-positive CHB, and in 31% more patients with HBeAg-negative CHB compared with placebo (p < 0.001). Additionally, adefovir dipivoxil therapy significantly improved virologic and biochemical parameters in both HBeAg-positive and -negative CHB patients. Adefovir dipivoxil offers important advantages over other CHB treatment options: it maintains activity against lamivudine-resistant CHB, has good efficacy against HBeAg-negative CHB, and has minimal adverse effects at the 10-mg/day Food and Drug Administration-approved dose.
Conclusions:
Approved medications for the treatment of CHB have many limitations, and adefovir dipivoxil provides a new important option as an initial treatment, as well as treatment in lamivudine-resistant patients.
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